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Search: "lead"

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William Monague Plate Set (Canadian Art Prints) – Lead Hazard (2024)

Product has been recalled because it may exceed FDA guidance levels for leachable lead.

Class IIModerate

FDAMar 11, 2024Nationwide• Canadian Art Prints

Cinnamon Powder (Mak Trading) – Elevated Lead Levels (2024)

Elevated levels of lead found in product

Class IIModerate

FDAMar 8, 2024CA, IN• Mak Trading Co. Ltd.

Ivenix Infusion System Software (Fresenius Kabi) – Potential Dosage Risks (2024)

Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

FDAMar 7, 2024CA, CO, ID +10 more• Fresenius Kabi USA, LLC

Bracelet (Skechers) – High Lead Levels (2024)

This recall involves the braided black bracelet that is a part of the Skechers watch/bracelet gift set. The bracelet is black and features a braided pattern with a metal clasp on each end. The watch in the gift set has a code number "IF2812307" printed on the back of the watch as well as "Sketchers" and model number "SR9082".

CPSCMar 7, 2024Nationwide• Fossil Group Inc., of Richardson, Texas

Cinnamon Powder (Raja Foods) – Lead Contamination (2024)

Product tested positive for lead

Class IIModerate

FDAMar 7, 2024AL, CT, FL +12 more• RAJA FOODS LLC

Ground Cinnamon (Colonna Brothers) – Lead Levels (2024)

Elevated lead levels in cinnamon

Class IIModerate

FDAMar 6, 2024Nationwide• Colonna Brothers Inc.

DxI 9000 Access Immunoassay Analyzer (Beckman Coulter) – Tank Crack (2024)

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

FDAMar 5, 2024Nationwide• Beckman Coulter, Inc.

t:connect Mobile App (Tandem Diabetes) – App Crash Risk (2024)

During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.

FDAMar 5, 2024Nationwide• Tandem Diabetes Care, Inc.

InflammaDry MMP-9 Test (Quidel) – Test Result Window Misalignment (2024)

There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

FDAMar 5, 2024AL, AK, AZ +41 more• Quidel Corporation

Ground Cinnamon (La Fiesta) – Lead Levels (2024)

Elevated levels of lead found in product

Class IIModerate

FDAMar 4, 2024AZ, CA, IN +2 more• la fiesta food products

Ground Cinnamon (El Chilar) – Lead Levels (2024)

Due to elevated levels of lead.

Class IIModerate

FDAMar 4, 2024IN, MD• EL Chilar-HF, LLC

ARCHITECT Anti-HCV Reagent Kit (Abbott) – False Elevated Results (2024)

Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

FDAMar 4, 2024Nationwide• Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany

NEOMED Pharmacy Syringes (Avanos) – Expiration Date Omission (2024)

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

FDAMar 4, 2024Nationwide• Avanos Medical, Inc.

Alinity i Anti-HCV Reagent Kit (Abbott) – False Elevated Results (2024)

FDAMar 4, 2024Nationwide• Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany

EZ2 Connect MDx-IVD (Qiagen) – Heater Cable Failure (2024)

Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost

FDAMar 4, 2024Nationwide• Qiagen Sciences LLC

6-Player Croquet Sets (Garden Games) - lead paint violation (2024)

This recall involves Sandford Family 6-Player Croquet Sets branded with either Garden Games or Big Game Hunters on the storage bag. The set includes four adult mallets; two winning posts; one red and blue children's mallet; six balls, clips and hoops, and a storage bag. The storage bag is branded with either a Big Game Hunters logo on a blue bag or a Garden Games logo on a green bag.

CPSCFeb 29, 2024Nationwide• Garden Games Ltd, of United Kingdom

BD Phoenix NMIC-306 Panel (Becton Dickinson) – Drug Cross Contamination (2024)

Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results

FDAFeb 29, 2024Nationwide• Becton Dickinson & Co.

VITROS Performance Verifier II (Ortho-Clinical Diagnostics) – Diluent Mismatch (2024)

The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.

FDAFeb 27, 2024Nationwide• Ortho-Clinical Diagnostics

VITROS Performance Verifier I (Ortho-Clinical Diagnostics) – Diluent Mismatch (2024)

FDAFeb 27, 2024Nationwide• Ortho-Clinical Diagnostics

LeadCare II Blood Test (Magellan) – Calibration Mislabeling (2024)

Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.

FDAFeb 23, 2024Nationwide• Magellan Diagnostics, Inc.

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